A sustained virologic response is durable in patients with chronic hepatitis C treated with peginterferon alfa-2a and ribavirin

Mark G. Swain, Ming-Yang Lai, Mitchell L. Shiffman, William G.E. Cooksley, Stefan Zeuzem, Douglas T. Dieterich, Armand Abergel, Mário G. Pessôa, Amy Lin, Andreas Tietz, Edward V. Connell, Moisés Diago

Received 25 January 2010; received in revised form 11 June 2010; accepted 8 July 2010. published online 15 July 2010.

Accepted Manuscript

Abstract

Background & Aims:
A sustained virologic response (SVR) to therapy for Hepatitis C virus (HCV) infection is defined as the inability to detect HCV RNA 24 weeks after treatment has been completed. Although small studies have reported that the SVR is durable and lasts for long time periods, it has not been conclusively demonstrated.

Methods:
The durability of treatment responses were examined in patients who were originally enrolled in 1 of 9 randomized, multicenter trials (n=1343). The study included patients who received peginterferon alfa-2a alone (n=166) or in combination with ribavirin (n=1077, including 79 patients with normal levels of alanine aminotransferase and 100 patients that were co-infected with HIV and HCV) and whose serum samples were negative for HCV RNA (<50 IU/mL) at their final assessment. Patients were assessed annually, from the date of last treatment, for a mean of 3.9 years (range 0.8–7.1).

Results:
Most patients (99.1%) that achieved an SVR had undetectable levels of HCV RNA in serum samples throughout the follow-up period. Serum samples from 0.9% of the patients contained HCV RNA after a mean period of 1.8 years (range 1.1–2.9 years) after treatment ended. It is not clear if these patients were re-infected or relapsed.

Conclusion:
In a large cohort of patients monitored for the durability of a SVR, the SVR was maintained for almost 4 years after treatment with peginterferon alfa-2a alone or in combination with ribavirin. In patients with chronic hepatitis C infection, the SVR is durable and these patients should be considered as cured.

Keywords: PEGASYS, cure, safety analysis, clinical outcome

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